Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-01 @ 6:22 AM
Study NCT ID:
NCT05033405
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuro Linguistic Programming Pain Levels After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020557', 'term': 'Neurolinguistic Programming'}], 'ancestors': [{'id': 'D008959', 'term': 'Models, Neurological'}, {'id': 'D008954', 'term': 'Models, Biological'}, {'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008960', 'term': 'Models, Psychological'}, {'id': 'D011578', 'term': 'Psycholinguistics'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study was conducted by using a prospective randomized single-blind clinical trial model.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examination of inter-and intra-group differences regarding VAS Scores', 'timeFrame': 'Immediately after the completion of the NLP application', 'description': 'A mean total score on the Visual Analogue Scale (VAS). In this assessment, users score their pain from 0 to 10. The scores are interpreted as follows: "0", no pain at all; 1-4, mild pain; 5-6, moderate pain; and 7-10, severe pain.\n\nA mean total score on the VAS of four and above indicates postoperative pain.'}], 'secondaryOutcomes': [{'measure': 'Distribution of participant characteristics by groups', 'timeFrame': '20 minutes after the first administration of the VAS', 'description': 'The effect of NLP application on post-operative pain in women who gave birth by cesarean section is examined. Comparisons are made by using Visual Analog Scale (VAS) mean scores in the experimental and control groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NLP, cesarean section, postpartum, pain'], 'conditions': ['Nursing Caries', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine the effect of Neuro-Linguistic Programming (NLP) application on post-cesarean section pain levels.', 'detailedDescription': "The study was carried out between March 1 and June 1, 2021 with mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital in the most populated city of Turkey, which is located in the west. The study data consists of a total of 76 individuals, including 38 in the experimental group and 38 in the control group. In the study, the effect size was calculated as 2.22. Accordingly, the power of the study, which was completed with 38 individuals in the control group and 38 in experimental group, had an effect size of 2.22, and used a significance level of 0.05, was calculated as 99.9%. The power analysis was conducted on the G\\*Power software package."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': "The mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study included individuals who\n\n * had a cesarean section,\n * were at the 6th to 24th hour postpartum,\n * agreed to participate in the study,\n * had a cesarean section for the first time,\n * did not use patient-controlled analgesia (PCA),\n * did not have an additional health problem that may cause pain in the postpartum period, other than cesarean incision pain, and\n * could speak and understand Turkish.\n\nExclusion Criteria:\n\n* Mothers who wanted to quit on their own will at any stage after being included in the study, had verbal communication problems, had hearing or vision problems, or had previously been diagnosed with a psychiatric illness were excluded from the sample.'}, 'identificationModule': {'nctId': 'NCT05033405', 'briefTitle': 'Neuro Linguistic Programming Pain Levels After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Munzur University'}, 'officialTitle': 'The Effect of Neuro Linguistic Programming on Pain Levels After Cesarean Delivery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '047213793060212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental:Neuro Linguistic Programming', 'description': 'One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field.', 'interventionNames': ['Behavioral: NEURO-LINGUISTIC PROGRAMMING (NLP)']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'No NLP was applied on the control group patients.'}], 'interventions': [{'name': 'NEURO-LINGUISTIC PROGRAMMING (NLP)', 'type': 'BEHAVIORAL', 'description': '● One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field', 'armGroupLabels': ['Experimental:Neuro Linguistic Programming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Tunceli', 'country': 'Turkey (Türkiye)', 'facility': 'Nursel Alp Dal', 'geoPoint': {'lat': 39.09921, 'lon': 39.54351}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Munzur University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asis. Prof.', 'investigatorFullName': 'Nursel Alp Dal', 'investigatorAffiliation': 'Munzur University'}}}}